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Trial record 7 of 965 for:    eczema

Randomized Controlled Trial of an Eczema Care Plan

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ClinicalTrials.gov Identifier: NCT02251340
Recruitment Status : Completed
First Posted : September 29, 2014
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Corinna Rea, Boston Children’s Hospital

Brief Summary:
The objectives of this project are to increase families' understanding of eczema and improve eczema management in the primary care setting. We have created an "Eczema Care Plan" similar to those used in the management of asthma. It gives specific instructions about medications, bathing and moisturizing, as well as when to seek further treatment. We will conduct a randomized controlled trial of the plan in Primary Care at Longwood for a 10 month period. Specifically, we aim to (1) decrease eczema severity (2) improve patient quality of life and (3) increase parental knowledge and confidence about eczema management. We also plan to track provider uptake and documentation of the plan and elicit feedback from parents and providers on the utility and feasibility of the plan.

Condition or disease Intervention/treatment Phase
Eczema Behavioral: Eczema Care Plan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of an Eczema Care Plan
Study Start Date : June 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Intervention
Families in the intervention group will receive an Eczema Care Plan
Behavioral: Eczema Care Plan
No Intervention: Control
Families in the control group will not receive an Eczema Care Plan



Primary Outcome Measures :
  1. proportion of patients with moderate/severe/very severe eczema [ Time Frame: 1 month for each patient ]
  2. quality of life measured via validated survey [ Time Frame: 1 month for each patient ]
  3. parental knowledge measured via survey [ Time Frame: 1 month for each patient ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:a) accompanying adult speaks English b) patient has a history of eczema c) patient is between the ages of 1 month and 16 years d) family is coming for an eczema visit or plans to discuss eczema e) accompanying adult is a primary caregiver f) child is not in foster care g) caregiver has not received an eczema care plan previously. -

Exclusion Criteria: a) accompanying adult does not speak English b) patient does not have a history of eczema c) patient is younger than 1 month or older than 16 years of age d) eczema will not be discussed at the visit e) accompanying adult is not the primary caregiver f) child is in foster care g) caregiver has received an eczema care plan previously.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251340


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital

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Responsible Party: Corinna Rea, Staff Physician, Instructor in Medicine, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02251340     History of Changes
Other Study ID Numbers: ChildrensH
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous